FDA Issues New Drug Labeling Rules Supporting Preemption of Warning Claims

March 2006
In its Final Rule designed to update and streamline labeling requirements for pharmaceuticals and biologics, the Food and Drug Administration has embraced implied preemption principles. Supporters view FDA’s commentary as a clear and simple reiteration of a long-standing perspective on preemption; detractors see FDA's statements on preemption as overstepping the bounds of FDA authority. FDA’s controversial preamble statements affirm its view offered in amicus briefs that its approval of prescription drug labeling preempts conflicting or contrary state law, including many aspects of failure to warn tort claims. The Final Rule, Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products Final Rule, effective June 30, 2006, can be found at www.fda.gov and 71 Fed. Reg. 3922 (January 24, 2006). “FDA believes that under existing preemption principles, FDA approval of labeling under the Act, whether it be in the old or new format, preempts conflicting or contrary State law.” Final Rule at p. 3934.

The concept of federal preemption, where a federal law which regulates particular conduct or a specific area will be deemed to preempt any state law which purports to regulate the same subject, applies only if Congress has demonstrated its intent to occupy the entire field of regulation or if the state law either contravenes or frustrates the purpose of the federal law. Thus, a finding of preemption is warranted if there is a direct conflict between state and federal law or where Congress has evidenced its intent, express or implied, to occupy a particular area. See Jones v. Rath Packing Co., 430 U.S. 519 (1977). President Clinton’s August 4, 1999 Executive Order No. 13132 (64 F.R. 43255) parallels the Supreme Court’s interpretation of federal preemption specifically the concepts of express, implied and conflict preemption, and requires that federal agencies construe a federal statute to preempt state law only where the statute contains an express preemption provision, or there is some other clear evidence that Congress intended preemption of state law, or where the exercise of state authority conflicts with the exercise of Federal authority under the federal statute. Exec. Order No. 13132, Sec. 4(a).

While many courts have declined to find that federal statutes governing the labeling of prescriptions drugs preempt state law tort claims (See e.g., Abbott v. American Cyanamid, 844 F.2d 1108 (4th Cir.) cert denied 488 U.S. 908 (1988)), some courts, recently revisiting the issue of conflict preemption (aided by amicus briefs filed by FDA) have found that although Congress has not expressly given FDA the power to preempt state requirements for prescription drug warnings, where state requirements actually conflict with the standards implemented by FDA, they are preempted, whether an express plan and clause exists in the FDCA or not. See e.g. Dusek v. Pfizer, Inc., 2004 Westlaw 2191804 (S.D. Tex. 2004) (appeal dismissed February 8, 2006.) FDA views itself as one of those few, elite federal agencies that may invoke preemptive authority. As the expert federal public health agency charged by Congress with ensuring that drugs are safe and effective and that their labeling adequately informs users of the risks and benefits of the product, FDA considers the pharmaceutical label or package insert, its “principal tool” for education about the risks and benefits of a drug. As such, FDA exercises this authority to carefully control label content, based on comprehensive scientific evaluations of the pharmaceutical product’s risks and benefits.

Viewing its authority over the content and format of a prescription drug product label as comprehensive, FDA rejects the notion offered by some courts that its labeling mandates are “minimum safety standards.” Rather, FDA interprets its regulatory powers to establish both a “floor” and “ceiling” on what constitutes the appropriate safety standard for prescription pharmaceuticals.

FDA’s preamble language strikes out at state courts and legislatures which attempt to punish pharmaceutical manufacturers for their failure to label a prescription drug product according to the whims of a state judge or jury. FDA believes that state law actions threaten FDA’s role as the expert federal agency responsible for drug evaluation and regulation, as such actions not characterized by centralized expert evaluation of drug and regulatory issues, but instead require lay persons and “lay judges” to reassess the risk-benefit analyses made by FDA. These less-informed reassessments and the disproportionate and excessive damage awards that frequently result from state tort law, puts pressure on manufacturers to defensively label to avoid state liability which, if implemented, could result in scientifically invalid, unsubstantiated warnings and under-utilization of otherwise beneficial drug treatments. It is up to either the drug sponsor or FDA itself to initiate a label change – judges and juries are ill-equipped to decide when it is appropriate to modify a drug’s package insert.

FDA rejects some state court holdings that manufacturers can add or strengthen warning statements in a drug label without first obtaining permission from FDA. Rather, FDA prefers that pharmaceutical manufacturers collaborate with FDA by consulting on labeling changes before doing so, to avoid charges of product misbranding. FDA warns state law requirements governing the labeling of prescription pharmaceuticals which are different from or in addition to those approved by FDA can undermine safe and effective use of the drug, cause meaningful risk information to lose its significance, and skew a product’s risk-benefit balance, encouraging inappropriate use of the drug and undermining the objectives of federal law. FDA determinations as to drug product safety and efficacy, and label adequacy are based “not on an abstract estimation of [a drug’s] safety and effectiveness, but rather on a comprehensive scientific evaluation.” Final Rule at p. 3934.

State and local governmental entities did not offer comments on the proposed rule, first issued in December 2000. Although states may have missed their opportunity to formally offer input to FDA on the preemptive effect of FDA regulations governing the content and format of labeling, plaintiffs’ attorneys have not. The Association of Trial Lawyers of America fears that if the new FDA rules go into effect, they could severely limit drug products liability suits. The ATLA plans to attack FDA’s new plan by lobbying Congress, reaching out to the media and teeing up the issue for judicial review as soon as possible. The Wall Street Journal reports that plaintiff attorneys may seek out states and judges that they perceive as more likely to reject FDA’s view of its authority over state law, including New York and New Jersey. Wall Street Journal, January 19, 2006 at D3.

This recent FDA initiative to garner more control over prescription drug labeling leaves all interested parties in pharmaceutical product liability litigation vulnerable to future judicial review. The newly proposed drug labeling rule will assist drug companies’ arguments that they were not required to warn about potential risks tied to a drug in situations where FDA has already determined that the safety issue did not warrant inclusion on a medicine’s labels. Having asserted itself as the preeminent authority on drug safety and efficacy issues, FDA has now decried product liability actions based on state law, noting that such actions can rely on interpretations of FDA regulations that conflict with the agency’s own interpretations and frustrate FDA’s implementation of its statutory mandate.

In summary, FDA rejected any notion that its regulations are a “minimum standard,” but rather the “gold standard,” as those regulations are based on comprehensive scientific review and risk-benefit analysis designed to protect the general public.

If you have any questions regarding this alert or other issues related to pharmaceutical liability litigation, please contact Judi Abbott Curry, Frederick H. Fern, Allan Fudim or Alan M. Winchester, or the Harris Beach attorney with whom you usually work at (212) 687-0100.

This Legal Alert provides a brief analysis or comments on matters related to FDA regulations and pharmaceutical liability litigation. This alert does not purport to be a substitute for advice of counsel on specific matters.